VP Medicine Development Leader

VP Medicine Development Leader

This is an exciting opportunity for an outstanding candidate to lead and drive all aspects of the development of an asset, bringing in and directing expertise from a number of different functions, ensuring its successful outcome and commercial launch. The role will be key in driving the refinement of a promising early pipeline, and by extension the successful growth and development of GSK as a business.

The role as MDL will be to strategically lead the optimal global development of a medicine, acting as the single point of accountability for the medicine from pre-Commit to Phase 2 Development (C2P2) to post-launch life-cycle management, delivering differentiated medicines of value.

By collaborating with the various stakeholders across R&D and Pharma, the MDL will define the strategic vision and operational plan for the medicine, aligning it with the overall organizational strategy.

The MDL will create and lead the matrix Medicine Development Team (MDT), which has responsibility for representing all the various R&D and commercial disciplines required to optimally deliver the development of the medicine (including clinical development, medical affairs, safety, regulatory, commercial and product development and manufacturing).

The role reports to Anna Shadman, SVP, Head of MDLs.

MDL Key Responsibilities in Detail

• Function as a single point of accountability in GSK for all aspects of a medicine in development globally from C2P2 (Commit to Phase 2) to approval in first major markets.
• Works closely with the Early Development Leader (EDL) and Medicine Commercialization Leader (MCL) to ensure a smooth transition between the EDL (accountable from Candidate Selection to Proof of Concept, Phase 1) to MDL (accountable from Phase 2 to approval in first major market) and from MDL to MCL (accountable from approval in first major market).
• Provide key support to the EDT (Early Development Team) leading up to C2P2 to ensure smooth transfer of accountability and a successful C2P2 and transition from phase 1 to phase 2.
• Provide key support to the MCT (Medicine Commercialisation Team) post-approval in first major markets ensuring that the MDT provide optimal support to both registration and Life Cycle Management.
• Selects members of the Medicines Development Team (MDT), in consultation with the line leaders, and leads this multi-disciplinary matrix team; supports differentiated development for team members; owns the performance of MDT and partners with line managers to drive performance.
• Establishes a compelling vision for the medicine; positions the medicine within the R&D strategy taking the competitive landscape into account; Translate GSK’s strategy into asset strategy and actionable plans for multiple areas or functions.
• Delivers differentiated medicines of value for patients, stakeholders, and markets, through an evidence package that supports regulatory approval, market access, and product life cycle.
• Delivers the Medicine Development Strategy that is aligned with the R&D disease strategy, as well as the asset Medicine Vision and Medicine Profile.
• Prioritizes and maximizes the assets portfolio options including developing multiple indications. Makes clear evidence-based go / no go / accelerate decisions, based on whether the results fulfil the strategy set out for the medicine, and identify clear inflection points
• Embeds core processes including cost efficiency, adoption of innovative technology, risk identification & management, compliance with policy
• Identifies and aligns resources (people and financial), team objectives and strategies behind the vision to ensure successful project completion
• Proactively identifies unmet medical needs that could be addressed through line extensions
• Enhances patient focus by incorporating the voice of the patient into development plans.
• Promotes organizational reputation and drives asset value by engaging and negotiating with internal and external stakeholders
• Collaborates with other stakeholders but EDLs and other MDLs to create strategies that support organizational vision; shares optimal ways of working and knowledge
• Ensures quality & compliance oversight in line with R&D expectations and project needs; assures quality of data and science
• Prioritizes and manages asset portfolio options to meet budget constraints.
• Ensures excellence in execution of all governance processes, including oversight of all studies, pharmacovigilance, scientific engagement, and promotional practices.

Why you?

Professional experience/ qualifications

Basic Qualifications:

• Advanced degree such as PhD, PharmD, MBA
• Drug development expertise and experience including filing experience, ideally in Immunology, Respiratory or Neuroscience
• Experience in product development and/or commercial, especially in late phase development (from PoC onwards), clinical trial management with significant operational complexity, post-approval studies, regulatory and manufacturing compliance
• Experience with the entirety of R&D across the development/commercial life cycle to allow impact across all functions: discovery, late-stage development, regulatory, manufacturing, and commercial.
• Experience working with regulators and regulatory requirements including an understanding of the legal and government frameworks within and across global geographies.
• People management experience, leadership, and motivational skills
• Experience creating the strategy for pre- and post-marketing studies and driving the lifecycle process.
• Experience of managing a sizable P&L which has organizational impact. Experience of building budgets and then leading the strategic and budget planning process
• Experience of leading with high operational complexity. Including global, geographically dispersed teams, multi-disciplinary structures with high accountability, minimal authority, and multiple lines of reporting

Preferred

In addition to the above, the following will be a differentiator:

Pivotal Experience & Expertise

• Asset Development Leadership Experience: Having previously operated in a similar role or environment to the GSK Medicine Development Leader, with end-to-end asset leadership including overseeing clinical development, medical affairs, safety, regulatory, commercial, product development and manufacturing, will be a distinct advantage.
• Therapeutic Area Experience: Previous direct experience in the therapeutic field of Immunology / Inflammation.
• Drug Development Expertise: Extensive and broad drug development experience and prior experience in leading successful development and registration of medicines is highly preferred.
• Record of success working in complex, matrixed, global, and multi-disciplinary organization with high accountability, minimal authority, and multiple lines of reporting.
• Project Management: experience of managing different business functions and creates alignment between different project indications and asset teams with different objectives.
• Ability to build relationships and create authentic alignment while leading high performing teams in a collaborative and purposeful manner to achieve defined objectives.
• Must be able to clearly demonstrate a thorough understanding of the healthcare environment including all key external stakeholders.
• Advanced ethics and integrity, with demonstrated ethical medical decision-making skills.

• Ability to work collaboratively and successfully across functions – research, commercial, regulatory, global medicine supply, legal, regions etc.

Leadership & Performance Characteristics

• A talented and experienced leader motivated by the desire to make a difference in patients’ lives.
• Excited by challenging goals and positively impacting the progression of medicines of value to patients that provide the adequate return to the business.
• Proven ability to think and plan uniquely and strategically, to collaborate with members of other functions within a matrix environment.
• Intrigued by innovation, creativity, and new opportunities to gain experience.
• Energized by delivering ambitious standards through collaboration and motivating others across the organization.
• Enthusiastic about developing others into future leaders.
• Committed to maintaining the highest compliance standards.

#LI-GSK

Why GSK?

We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

No single scientist, nor any one technology can keep us all ahead of disease. That’s why we build important collaborations with commercial and academic partners to advance our understanding of disease and what it takes to get ahead. In the past three years, we’ve doubled the number of partnerships we’ve signed, because of our belief in their significant impact on our process.

Our pipeline currently comprises of more than 69 vaccines and medicines across four core therapeutic areas including infectious diseases, HIV, oncology, and immunology as well at pursuing other science-led opportunities outside our core areas. Many have the potential to be first or best-in-class opportunities for patients and since 2017, we’ve delivered over 20 approvals.

We give our scientists the freedom to own the process. Our scientists often use genetic data to help us understand the root cause of disease. We steer the research where the data shows we can do the most good. If a project doesn’t pan out, we take what we’ve learned and apply it elsewhere.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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